What are the terms GMP and cGMP?
Hi everyone!!
Someone could give me some information about cGMP? I have a Spanish client that exports his products to EU and US. He would like to obtain the GMP+ certification but I think for EU he'll need cGMP. Can anyone give me some advice??? thanks
Hi everyone!!
Someone could give me some information about cGMP? I have a Spanish client that exports his products to EU and US. He would like to obtain the GMP+ certification but I think for EU he'll need cGMP. Can anyone give me some advice??? thanks
Hi TC,
Maybe try googling cGMP - It's American.
In food sector GMP and cGMP are not a lot different. But if you are working on pharmaceuticals or nutraceuticals, you may need their relevant cGMP. I would recommend that you read cGMP based on the FDA codes so you can be fully compliant.
You can read more about cGMP for drugs in the following FDA codes:
- Title 21: CFR Part 314
- Title 21: CFR Part 210
- Title 21: CFR Part 211
- Title 21: CFR Part 212
- Title 21: CFR Part 600
For food I would mostly consider GMP in other countries and in the US go to the following cGMP is needed:
- Title 21: CFR Part 117 sub part B (Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food)
Hi everyone!!
Someone could give me some information about cGMP? I have a Spanish client that exports his products to EU and US. He would like to obtain the GMP+ certification but I think for EU he'll need cGMP. Can anyone give me some advice??? thanks
If cGMP came up, I'm going to guess this is a potentially FDA regulated (non-meat) food item? The FDA in its infinite wisdom tried to reinvent the wheel in regards to a variety of food safety terms and principles after the FSMA.